Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $1.3 million, down from $3.1 million in Q4 2024, representing a decline of approximately 58.1% [23] - For the full year 2025, total revenue was $6.4 million, compared to $29.6 million in 2024, a decrease of about 78.4% [23] - Total operating costs and expenses for Q4 2025 were $14.8 million, up from $10.3 million in Q4 2024 [23] - For the full year 2025, total operating costs and expenses were $52.3 million, significantly reduced from $180 million in 2024 [23] - The net loss for Q4 2025 was $14.6 million, or $3.61 per share, compared to a net loss of $8.7 million, or $2.15 per share in Q4 2024 [25] - The net loss for the full year 2025 was $58.2 million, or $14.40 per share, down from a net loss of $153.1 million, or $38.26 per share in 2024 [25] - As of December 31, the company reported $109.4 million in cash equivalents, investments, and accounts receivable, with a cash runway expected into 2028 [26] Business Line Data and Key Metrics Changes - The company is advancing the FG-3246 program, a potential first-in-class antibody drug conjugate targeting CD46 in metastatic castration-resistant prostate cancer [4][5] - The FG-3246 program is expected to address a significant unmet need in late-stage prostate cancer, with an estimated total addressable market of over $5 billion annually in the U.S. [8] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a significant opportunity due to the lack of oral treatments currently available [18][22] Market Data and Key Metrics Changes - Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S., with about 65,000 drug-treatable patients with metastatic disease that has become castration-resistant [7] - The incidence of grade 3 or greater neutropenia was substantially reduced with the utilization of GCSF prophylaxis in ongoing trials [12] Company Strategy and Development Direction - The company aims to rebrand from FibroGen to Kyntra Bio to better reflect its focus on oncology and rare diseases [7] - The strategy includes advancing mid and late-stage assets and simplifying the capital structure to create value for shareholders [7] - The company is focused on developing FG-3246 and its companion FG-3180 program, with expected interim analysis from the phase 2 monotherapy trial in the second half of 2026 [27] Management's Comments on Operating Environment and Future Outlook - Management highlighted 2025 as a transformational year, emphasizing the importance of reducing fixed costs to maximize cash runway and invest in U.S. pipeline opportunities [26] - The company remains confident in its positioning to create meaningful therapeutic options for patients and significant value for shareholders [7] Other Important Information - The company has received orphan drug designation for roxadustat, which provides a minimum of 7 years of regulatory exclusivity [22] - The company is exploring opportunities to develop roxadustat internally or with a strategic partner [21] Q&A Session Summary Question: Imaging of CD46 opportunity and commercial potential - Management discussed the potential market for CD46 PET imaging agents and how they would fit into the treatment algorithm alongside existing PSMA agents [30][32] - The company anticipates that patients will need to show positive uptake of CD46 PET imaging to be prescribed FG-3246, similar to the requirements for PSMA agents [34] Question: SUV data and patient selection - Management acknowledged the provocative nature of the SUV data and its potential role in enriching patient selection for treatment [30][40] - The phase 2 trial is designed to define CD46 positivity, which may be based on SUV or other metrics [40] Question: Balance of patients in studies and recruitment - Management clarified that the phase 2 monotherapy trial will focus on patients who have progressed on only one prior ARPI, differentiating it from the IST [46] Question: Updates on roxadustat partnering efforts - Management stated that they are evaluating the opportunity to develop roxadustat internally or through collaboration but did not provide specific updates on the partnering process [49] Question: FDA feedback timeline for roxadustat - Management explained that the FDA indicated a feedback timeline of 60-90 days due to the nature of the protocol submission, which is currently being awaited [53]

Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $1.3 million, down from $3.1 million in Q4 2024 [23] - For the full year 2025, total revenue was $6.4 million, compared to $29.6 million in 2024 [23] - Total operating costs and expenses for Q4 2025 were $14.8 million, up from $10.3 million in Q4 2024 [23] - Total operating costs and expenses for the full year 2025 were $52.3 million, down from $180 million in 2024 [23] - R&D expenses for Q4 2025 were $7.3 million, compared to $6.9 million in Q4 2024 [24] - R&D expenses for the full year 2025 were $23.5 million, down from $95.7 million in 2024 [24] - SG&A expenses for Q4 2025 were $7.3 million, compared to $8.3 million in Q4 2024 [24] - SG&A expenses for the full year 2025 were $27.7 million, down from $49.3 million in 2024 [24] - The net loss from continuing operations for Q4 2025 was $14.6 million, compared to a net loss of $8.7 million in Q4 2024 [25] - The net loss from continuing operations for the full year 2025 was $58.2 million, compared to a net loss of $153.1 million in 2024 [25] - As of December 31, 2025, the company reported $109.4 million in cash equivalents, investments, and accounts receivable, with a cash runway expected into 2028 [26] Business Line Data and Key Metrics Changes - The company is advancing the FG-3246 program, a potential first-in-class antibody drug conjugate targeting CD46 in metastatic castration-resistant prostate cancer [4][5] - The FG-3246 program is expected to address a significant unmet need in late-stage prostate cancer, with an estimated total addressable market of over $5 billion annually in the U.S. [7][8] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a significant opportunity due to the lack of oral treatments currently available [18][22] Market Data and Key Metrics Changes - Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S., with about 65,000 drug-treatable patients with metastatic disease [7] - Current treatments for anemia associated with lower-risk MDS are effective in less than 50% of patients, highlighting the need for new therapies [18] Company Strategy and Development Direction - The company aims to rebrand from FibroGen to Kyntra Bio to better reflect its focus on oncology and rare diseases [7] - The strategy includes advancing mid and late-stage assets and simplifying the capital structure to create value for shareholders [7] - The company plans to initiate a phase III trial for roxadustat in the second half of 2026 [21][27] Management's Comments on Operating Environment and Future Outlook - Management highlighted 2025 as a transformational year, emphasizing the importance of reducing fixed costs to maximize cash runway [26] - The company remains confident in its clinical programs and the potential for FG-3246 and FG-3180 to provide meaningful therapeutic options [7][27] Other Important Information - The company has received orphan drug designation for roxadustat, which provides a minimum of seven years of regulatory exclusivity [22] - The company is actively enrolling patients for the FG-3246 phase II trial and expects interim results in the second half of 2026 [15][27] Q&A Session Summary Question: Imaging of CD46 opportunity and commercial potential - Management discussed the positioning of CD46 PET imaging agents in relation to existing PSMA agents and the anticipated commercial opportunity [30][32] Question: SUV data and patient selection - Management addressed the correlation between SUV data and patient selection, noting the need to define CD46 positivity metrics in the phase II trial [30][40] Question: Balance of patients in studies - Management clarified that the phase II monotherapy trial will focus on patients who have progressed on one prior ARPI, differentiating from the IST [46] Question: Updates on roxadustat partnering efforts - Management indicated ongoing evaluations for internal development versus potential collaborations for roxadustat but did not provide specific updates [49] Question: Delay in FDA feedback for roxadustat - Management explained the expected timeline for FDA feedback on the IND submission, indicating a 60-90 day period for response [53][54]

Fourth Quarter and Full Year 2025 Financial Results March 16, 2026 Forward-Looking Statements This presentation contains forward-looking statements regarding Kyntra Bio's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and pr ...

Company Overview - Kyntra Bio rebranded from FibroGen, Inc. in January 2026, with its common stock trading under the new Nasdaq symbol "KYNB" [28]. - The company closed the sale of its China operations to AstraZeneca for a total consideration of $220.4 million, including $85.0 million in enterprise value and $135.4 million in net cash [30]. Product Development - Kyntra Bio is developing FG-3246, a potential first-in-class ADC targeting CD46 for mCRPC, with a Phase 2 monotherapy dose optimization study initiated in Q3 2025 [28][40]. - The ongoing Phase 2 trial of FG-3246 aims to enroll 75 patients, with interim results expected in the second half of 2026 [42]. - In a prior Phase 1 study, FG-3246 demonstrated a confirmed objective response rate of 20% and a disease control rate of 80% in mCRPC patients [44]. - Kyntra Bio is heavily reliant on the commercial success of its lead products, roxadustat and FG-3246, with ongoing development for metastatic castration-resistant prostate cancer (mCRPC) using the PET imaging agent FG-3180 [145]. Roxadustat Overview - Roxadustat is currently approved in multiple countries for treating anemia in CKD patients, with significant unmet medical needs in lower-risk MDS patients [29][54]. - The FDA granted Roxadustat Orphan Drug Designation for the treatment of MDS in December 2025, with a positive Type-C meeting held in July 2025 regarding the Phase 3 study design for anemia associated with lower-risk MDS [33][32]. - Roxadustat stimulates the body's natural RBC production and iron hemostasis, providing a potential safe and convenient option for lower-risk MDS patients [54]. - The company has retained rights to roxadustat in the U.S., Canada, and Mexico, while Astellas is responsible for commercialization in Europe and Japan [64]. Clinical Trials and Regulatory Approvals - The Phase 3 trial for roxadustat is planned to include approximately 200 patients with lower-risk MDS, focusing on RBC transfusion independence as a primary endpoint [59]. - In the Phase 2/3 clinical trial, 47.5% of patients in the roxadustat arm achieved transfusion independence for 56 consecutive days compared to 33.3% in the placebo arm, although the p-value was not significant [61]. - The FDA requires a 60-day review period after NDA or BLA submission acceptance, during which it assesses product safety, efficacy, and manufacturing compliance [90]. - Post-approval, drugs remain under FDA regulation, including recordkeeping and reporting of adverse experiences [91]. Financial Aspects - The company received $49.8 million from a revenue interest financing agreement with NovaQuest related to future revenues from Astellas' sales of roxadustat [77]. - The global MDS market was estimated at approximately $3 billion in 2023 and is projected to reach approximately $5 billion by 2030, reflecting a CAGR of about 9% from 2024 to 2030 [55]. Intellectual Property - Roxadustat composition-of-matter patents are set to expire in 2024 in most regions, except in the U.S. where they will expire in 2025, while additional patents related to its crystalline form and key intermediates will expire in 2033 [124]. - The European Patent No. 3470397 for roxadustat formulations has been granted, extending patent protection to 2036 [125]. - FG-3246 patent portfolio includes patents expiring in 2035 for composition-of-matter and in 2041 for pharmaceutical compositions and dosing [126]. - The company may apply for patent term restoration under the Hatch-Waxman Act, potentially extending patent life by up to five years [111]. Compliance and Regulatory Risks - Compliance with various data privacy laws, such as the CCPA and EU GDPR, imposes significant obligations and potential penalties for noncompliance [101]. - The company faces risks from healthcare reform measures that may reduce reimbursement and impose pricing pressures [107]. - Regulatory approval processes vary significantly across countries, affecting the timeline for product launches in international markets [109]. - The company must ensure compliance with rigorous regulatory standards throughout the clinical trial process to maintain credibility and protect trial participants [149]. Employee Engagement and Diversity - As of December 31, 2025, the company had 34 employees in the U.S., with a 100% participation rate in a recent employee engagement survey [133][135]. - The company achieved a 96% positive employee sentiment regarding diversity, equity, and inclusion in 2025, up from 86% in 2024 [135]. - The Board of Directors consists of 20% female members and 20% identifying as Asian ethnicity, with the U.S. workforce being 45% female [138]. Market Challenges - The company faces substantial competition in the development and commercialization of product candidates, particularly in the prostate cancer market [173]. - Market acceptance of product candidates is uncertain, and inadequate reimbursement from payors may limit attractiveness to patients and providers [180]. - The company may need to conduct additional clinical trials to obtain or maintain reimbursement or pricing approval in various countries [184]. Supply Chain and Manufacturing Risks - The company relies on third-party manufacturers for production and distribution, which may lead to reduced control and potential delays in commercialization [196]. - Supply chain logistics, including importing materials from countries like China and India, add risks of delays and potential shortages [204]. - The company relies on single-source suppliers for certain components, and loss of these suppliers could materially affect business operations [203]. Legal and Regulatory Compliance - Compliance with healthcare fraud and abuse laws is critical, as violations could lead to substantial penalties and affect the company's financial results [223]. - Legal proceedings related to healthcare regulations may incur significant expenses and distract management, potentially adversely affecting share prices [225]. - The company is subject to stringent data privacy and security laws, with non-compliance leading to regulatory actions and reputational harm [226].

Exhibit 99.1 Kyntra Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update SAN FRANCISCO, March 16, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today reported financial results for the fourth quarter and full year 2025 and provided an update on the company's recent developments. "The encouraging results from the investigator-sponsored combination trial of FG-3246 with enzalutamide provide us with valuable insights and reinforce key design elements in our Phase 2 ...

Kyntra Bio Conference Call Summary Company Overview - **Company Name**: Kyntra Bio (formerly FibroGen) - **Ticker**: NasdaqGS:FGEN - **Event**: 2026 Conference on March 11, 2026 Key Highlights Company Transformation - Kyntra Bio transitioned from FibroGen to enhance impact for patients and shareholders [2] Financial Developments - Completed the sale of FibroGen China to AstraZeneca for approximately $220 million, including $135 million in cash [3] - Paid off a $75 million term loan facility and extended cash runway into 2028 [3] Product Pipeline FG-3246 and FG-3180 - FG-3246 is a potential first-in-class therapy targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC) [4] - FG-3180 is a PET imaging agent in clinical development for patient selection [4] - Phase II trial for FG-3246 has commenced, focusing on mCRPC patients [5] Roxadustat - Roxadustat is a phase III-ready treatment for anemia associated with lower risk myelodysplastic syndrome (MDS) [5] - Approved in over 40 countries for anemia related to chronic kidney disease [5] - Kyntra Bio owns Roxadustat in North America, South America, and Australia [5] Clinical Trials and Data FG-3246 Phase 1 Results - Phase 1 trial showed an rPFS of 8.7 months and a 36% PSA50 response rate in heavily pretreated mCRPC patients [17] - Notable adverse events included 36% grade three or above neutropenia and 34% peripheral neuropathy [18] FG-3246 and Enzalutamide Combination - Phase 1B/2 trial showed 7 months rPFS across the entire cohort and 10.1 months for patients who progressed on one prior ARPI [21] - Strong correlation between CD46 tumor uptake and PSA50 response [23] Regulatory and Market Opportunities - Received orphan drug designation from the FDA for myelodysplastic syndrome, providing seven years of regulatory exclusivity upon approval [6] - Roxadustat aims to address unmet needs in lower risk MDS, with a focus on patients requiring 4 or more RBC units [31][36] - The worldwide MDS market is projected to exceed $4 billion in the next five years, presenting a significant commercial opportunity [38] Strategic Focus - Kyntra Bio is exploring multiple lines of therapy in prostate cancer and aims to leverage the unique properties of FG-3246 and FG-3180 [29] - The company is committed to developing Roxadustat as an oral alternative for elderly patients with MDS, addressing convenience and efficacy across different patient populations [37] Conclusion Kyntra Bio is positioned to capitalize on significant opportunities in oncology and hematology, with a robust pipeline and strategic focus on addressing unmet medical needs in mCRPC and lower risk MDS. The company is actively advancing its clinical trials and regulatory strategies to enhance its market presence and shareholder value.

Forward-Looking Statements This presentation contains forward-looking statements regarding Kyntra Bio's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and product candidates, statements under the caption "Recent and Near-Ter ...

Summary of Kyntra Bio Conference Call Company Overview - **Company Name**: Kyntra Bio (formerly FibroGen) - **Focus**: Transitioned from fibrosis and collagen to oncology and rare diseases, reflecting a strategic transformation to leverage current momentum in these areas [1][2] Financial Highlights - **Sale of FibroGen China**: Completed sale to AstraZeneca for $220 million, which helped pay off senior secured debt and simplified capital structure [2][3] - **Cash Runway**: Extended into 2028, allowing for continued development of clinical programs [3] Clinical Development Programs FG-3246 and FG-3180 - **Indication**: Metastatic castration-resistant prostate cancer (mCRPC) - **Phase 2 Trial**: Initiated for FG-3246 (first-in-class targeting CD46) and FG-3180 (companion PET imaging agent) with interim results expected later this year [3][4] - **Clinical Responses**: Previous studies indicated meaningful clinical responses; 50%-70% of mCRPC patients express CD46 [10][53] Roxadustat - **Indication**: Anemia associated with lower-risk myelodysplastic syndromes (MDS) - **Commercial Opportunity**: Competing against luspatercept, which is projected to generate $2.3 billion in revenue by 2025, primarily in the U.S. [26] - **Regulatory Path**: Received orphan drug designation and is preparing for a phase 3 trial [5][31] Clinical Trial Insights - **Phase 1 Monotherapy Results**: Demonstrated a radiographic progression-free survival (RPFS) of 8.7 months in heavily pre-treated patients [13] - **Adverse Events**: Notable rates of neutropenia and peripheral neuropathy observed; strategies to mitigate these effects are being implemented [14][15][18] - **PET Imaging Correlation**: Evidence of correlation between CD46 expression and treatment response, which will be further evaluated in ongoing trials [20][21][54] Market Position and Strategy - **Unmet Need**: Significant unmet need in mCRPC, particularly for patients ineligible for or who have progressed on existing therapies [6][8] - **Targeted Approach**: Focus on non-PSMA approaches and the potential for combination therapies to enhance treatment efficacy [7][46] - **Patient Selection**: Utilizing PET imaging to select patients with high CD46 expression for better treatment outcomes [50][53] Future Outlook - **Upcoming Catalysts**: Anticipated interim results from ongoing trials and potential regulatory feedback on phase 3 protocols [5][6][32] - **Strategic Partnerships**: Engaging in discussions for potential business development opportunities while considering self-funding for trials [32] Conclusion Kyntra Bio is positioned to capitalize on its innovative oncology pipeline, particularly in mCRPC and MDS, with a strong focus on leveraging clinical data and strategic partnerships to enhance its market presence and patient outcomes [32][33]

Core Viewpoint - Kyntra Bio announced promising preliminary data on the anti-tumor activity of FG-3246 in combination with enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC), with results to be presented at the 2026 ASCO GU symposium [1][2] Study Results - The Phase 1b/2 study showed a composite response rate of 21% in the overall cohort and 40% in patients who had progressed on only one prior androgen receptor pathway inhibitor (ARPI) [3] - Median radiographic progression-free survival (rPFS) was 7.0 months in the overall cohort, with a notable 10.1 months in patients who had only one prior ARPI [3][4] - Higher tumor uptake of FG-3180 indicated a trend towards a higher probability of PSA50 response (p=0.053), suggesting its potential as a biomarker for patient selection [3][4] Safety Profile - The combination therapy of FG-3246 and enzalutamide exhibited a safety profile similar to that observed in previous trials, with neutropenia risk mitigated through G-CSF prophylaxis [4][5] - Common treatment-related adverse events (TRAEs) included fatigue, peripheral neuropathy, anorexia, and dysgeusia, with some patients discontinuing treatment due to cumulative toxicities [5] Future Developments - Kyntra Bio is on track to provide interim analysis results from the Phase 2 monotherapy trial of FG-3246 in the second half of 2026, which will further explore the utility of FG-3180 as a patient selection biomarker [4][6] - FG-3246 is being developed as a first-in-class antibody-drug conjugate targeting CD46, with potential applications in other tumor types beyond mCRPC [7][9]

Core Insights - FibroGen, Inc. is rebranding to Kyntra Bio, focusing on oncology and rare disease assets, with trading under the new Nasdaq symbol "KYNB" starting January 8, 2026 [1][6] Company Transformation - 2025 was a pivotal year for the company, marked by the sale of FibroGen China, repayment of a senior secured term loan, and extending its cash runway into 2028 [2] - The rebranding reflects a sharpened focus on mid- and late-stage assets, particularly FG-3246, a CD46 targeting antibody drug conjugate, and FG-3180, a companion PET imaging agent in a Phase 2 trial for prostate cancer [2][4] Product Development and Clinical Trials - Roxadustat, approved in multiple countries for treating anemia in chronic kidney disease, is being evaluated for a Phase 3 trial in the U.S. for lower-risk myelodysplastic syndromes [4] - FG-3246 is in Phase 2 development for metastatic castration-resistant prostate cancer, with interim results from the ongoing monotherapy trial expected in the second half of 2026 [7] - The company has received Orphan Drug Designation from the FDA for myelodysplastic syndromes and submitted a pivotal Phase 3 clinical trial protocol for roxadustat [7] Corporate Strategy - The company is refreshing its corporate website to align with its new strategic direction [3] - Kyntra Bio aims to create a significant impact for patients and shareholders through its focused approach on novel therapies [2][6]